The FDA has released a new roadmap outlining a path toward reducing—and ultimately replacing—animal studies in pharmaceutical development with new approach methodologies (NAMs), beginning with monoclonal antibodies. This evolving regulatory landscape presents exciting opportunities and both scientific and operational implications for drug developers.

In this webinar, experts from Simulations Plus will provide an overview of the FDA’s roadmap, discuss its relevance to current development practices, and examine what is achievable today with modeling and simulation (M&S) tools in support of this transition. Presenters will share practical approaches for integrating M&S into development programs, with a particular focus on biologics and monoclonal antibodies.

Topics will include:

• Key elements of the FDA’s roadmap and their impact on development strategies
• Incorporating model-informed approaches into early- and late-stage development
• Case studies demonstrating the use of M&S in lieu of animal studies
• Regulatory considerations and alignment with MIDD initiatives

At the end of the discussion, attendees will have the opportunity to ask questions during a live Q&A.

This session is intended for professionals involved in preclinical and clinical development who are seeking to understand how in silico tools can contribute to scientifically sound and regulatory-aligned alternatives to animal testing.

WEBINAR PANELISTS:

• Sandra Suarez-Sharp (moderator), President, Regulatory Strategies Center of Excellence, Simulations Plus
• Susie Zhang, Vice President, Regulatory Strategies, Simulations Plus
• Scott Q. Siler, Chief Science Officer, QSP, Simulations Plus
• Viera Lukacova, Chief Scientist, PBPK, Simulations Plus
• Timothy McGovern, Co-Founder, Principal Consultant at White Oak Regulatory Tox, LLC